| CTRI Number |
CTRI/2024/08/073105 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Antibiotic of Preference: CEFOTAXIME VS MEROPENEM AS EMPIRICAL TREATMENT IN SPONTANEOUS BACTERIAL PERITONITIS
|
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF CEFOTAXIME VS MEROPENEM AS EMPIRICAL TREATMENT IN SPONTANEOUS BACTERIAL PERITONITIS
|
| Trial Acronym |
SBP CURE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. RISHABH PARASHAR |
| Designation |
DM SENIOR RESIDENT |
| Affiliation |
JLN MEDICAL COLLEGE, AJMER |
| Address |
46, NIRMAL VIHAR, BENAD ROAD, NEAR DADI KA PHATAK, JHOTWARA, JAIPUR, RAJASTHAN
Jaipur
RAJASTHAN
302012
India |
| Phone |
8003160572 |
| Fax |
|
| Email |
drrishabhparashar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. M.P.SHARMA |
| Designation |
SENIOR PROFESSOR AND HOD |
| Affiliation |
JLN MEDICAL COLLEGE, AJMER |
| Address |
DEPT OF GASTROENTEROLOGY, 2ND FLOOR, JLN HOSPITAL ,AJMER
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414047131 |
| Fax |
|
| Email |
gastrojlnmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RISHABH PARASHAR |
| Designation |
DM SENIOR RESIDENT |
| Affiliation |
JLN MEDICAL COLLEGE, AJMER |
| Address |
DEPT OF GASTROENTEROLOGY, 2ND FLOOR, JLN HOSPITAL, AJMER
Ajmer
RAJASTHAN
305001
India |
| Phone |
8003160572 |
| Fax |
|
| Email |
drrishabhparashar@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN MEDICAL COLLEGE, KALA BAGH, AJMER, RAJASTHAN (INDIA)
PIN-305001 |
|
|
Primary Sponsor
|
| Name |
JLN MEDICAL COLLEGE AJMER |
| Address |
JLN MEDICAL COLLEGE, KALA BAGH, AJMER, RAJASTHAN (INDIA)
PIN-305001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RISHABH PARASHAR |
JLN HOSPITAL, AJMER |
DEPT OF GASTROENTEROLOGY, 2ND FLOOR, JLN HOSPITAL,KALA BAGH, AJMER, RAJASTHAN
PIN-305001
Ajmer
RAJASTHAN |
8003160572
drrishabhparashar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, JLN MEDICAL COLLEGE, AJMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj CEFOTAXIME |
1 GM I.V. TDS for 3 days |
| Comparator Agent |
Inj. MEROPENEM |
1 gm I.V. TDS for 3 says |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Liver cirrhosis patients with ascitic fluid PMN cell count greater than 250/mm3 (treatment naive).
2.Age equal or greater than 18 years.
3.Patient who give informed consent.
|
|
| ExclusionCriteria |
| Details |
1.History of abdominal surgery within 4 weeks
2.Secondary peritonitis
3.Tuberculous peritonitis
4.Malignant ascites
5.Patients on immunosuppressants
6.AIDS patients.
7.Creatinine clearance less than 50 mL/min.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Follow-up paracentesis after 48 hours of initiation of empirical antibiotic treatment showing reduction in neutrophil count of at least 25% or
Decrease of peritoneal fluid PMN count to less than 250 cells/μ and negative previously positive ascitic fluid culture. |
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| role of serum procalcitonin as a marker of SBP |
At baseline & after 2 days |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Spontaneous Bacterial Peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. Gram negative enteric bacteria are considered the most common pathogens responsible for SBP. Third generation cephalosporins are the recommended drugs for treating Spontaneous Bacterial Peritonitis empirically. Recent studies have shown that effectiveness of cephalosporins has decreased in community acquired and hospital acquired SBP. Meropenem is being used in treatment of drug resistant and hospital acquired SBP. This study aims to evaluate and compare the effectiveness of cefotaxime vs meropenem as empirical treatment in SBP This study is hospital based clinical trial study at JLN hospital, Ajmer. SBP was diagnosed based on the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in liver cirrhosis patients in the absence of an intra-abdominal source of infection or malignancy. 54 subjects will be taken in study and randomized into two groups. One group will be given cefotaxime and another group meropenem. Efficacy of antibiotic therapy will be checked with follow-up paracentesis after 48 hours of initiation of empirical antibiotic treatment showing reduction in neutrophil count of at least 25% or decrease of peritoneal fluid PMN count to < 250 cells/ mm3 and negative previously positive ascitic fluid culture. Outcome of treatment will be compared in both groups. |